Urine Tumor DNA Testing for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method for detecting non-muscle invasive bladder cancer using urine tumor DNA, potentially reducing the need for cystoscopy procedures (a camera-based examination inside the bladder). Researchers are studying the UroAmp Test (a urine DNA test) to determine if it can be as effective as regular check-ups. Participants are divided into two groups: one receives regular follow-ups, while the other undergoes fewer cystoscopies. Suitable candidates have high-risk bladder cancer, have undergone treatments like BCG or gemcitabine/docetaxel, and have a clear initial post-treatment check-up. As an unphased trial, this study offers patients the chance to contribute to innovative research that could simplify future bladder cancer monitoring.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that the UroAmp Test is safe for use in bladder cancer surveillance?
Studies have shown that the UroAmp test is safe. In research involving 66 patients and 933 test instances, no serious side effects occurred. Only mild side effects appeared, indicating that the test is generally well-tolerated. No reports of severe reactions emerged, which reassures those considering joining a trial using this test.12345
Why are researchers excited about this trial?
Researchers are excited about the UroAmp Test for bladder cancer because it offers a non-invasive way to detect tumor DNA through urine samples. Traditional methods often rely on frequent cystoscopy, which is more invasive and uncomfortable for patients. The UroAmp Test aims to simplify monitoring by identifying cancerous cells without the need for invasive procedures, potentially leading to earlier detection and less frequent medical visits. This approach could significantly improve patient comfort and compliance while maintaining effective surveillance for bladder cancer.
What evidence suggests that the UroAmp Test is effective for detecting non-muscle invasive bladder cancer?
Research has shown that the UroAmp test is promising for detecting bladder cancer. Studies have found that UroAmp can identify cancer that other methods, such as a bladder exam with a camera (cystoscopy) or a urine test for cancer cells (urine cytology), might miss. One study revealed that patients who tested positive with UroAmp were more likely to experience cancer recurrence compared to those who tested negative. This suggests that UroAmp can help identify patients at higher risk of cancer returning. In this trial, participants in the De-Intensified Arm will undergo less-frequent cystoscopy surveillance, potentially guided by UroAmp results. Overall, UroAmp could be a valuable tool in tailoring bladder cancer treatment by identifying those who might need closer monitoring.16789
Who Is on the Research Team?
Matthew B Clements, MD, MS
Principal Investigator
Lahey Hospital & Medical Center
Are You a Good Fit for This Trial?
This trial is for individuals with non-muscle invasive bladder cancer. It's designed to see if a urine test can help reduce the number of times they need cystoscopy, which is a procedure that looks inside the bladder.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are assigned to either standard surveillance or de-intensified surveillance based on urine tumor DNA (utDNA) testing
Interim Analysis
Evaluation of conversion rate from low-risk to high-risk on the utDNA test after 50% enrollment
Follow-up
Participants are monitored for event-free survival, recurrence-free survival, and patient-reported outcomes
What Are the Treatments Tested in This Trial?
Interventions
- UroAmp Test
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lahey Clinic
Lead Sponsor